Adjuvant Quisinostat in High-Risk Uveal Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Miami
About this trial
The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of uveal melanoma (UM) with a lesion of at least 12 mm in largest basal diameter (LBD) as clinically determined by the treating Investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g., by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy.
Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy.
High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX).
No evidence of metastatic disease.
Disqualifiers
Additional malignancy that is progressing or requires active treatment. Exceptions include the following cancers: basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, elevated levels of prostate-specific antigen (PSA) stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 2 years or longer.
Any major surgery or extensive radiotherapy except that which is required for definitive treatment of primary UM.
Previous adjuvant treatment for UM after definitive primary tumor therapy.
History of prior Histone Deacetylase (HDAC) inhibitor use.
Trial design
Design model
Single group
Treatments tested in this trial
Quisinostat
DrugParticipants will receive 12 mg of Quisinostat via capsule to be taken orally three times per week of each 21 day cycle.
Treatment groups
63 Participants
are divided into 1 treatment groupGroup A: Quisinostat Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Distant metastasis-free survival (DMFS) Rate
The distant metastasis-free survival (DMFS) rate among participants will be reported. DMFS is defined as the elapsed time in months from the date of study entry until the appearance of distant metastases or death, whichever occurs first. Participants who have not had an event will be censored at the date of last disease assessment documenting the patient was free of disease metastases. DMFS will be assessed from start of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
Up to 36 monthsSecondary outcomes
1
Progression-free Survival (PFS)
PFS is defined as the elapsed time in months from the date of study entry until disease progression, which will include both local/regional recurrences and distant metastatic disease recurrences or death, whichever occurs first. Alive patients who have not had an event will be censored at the date of last disease assessment documenting that the patient was free of progression. PFS will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame
Up to 36 months2
Overall Survival (OS)
Overall survival (OS) is defined as the elapsed time in months from start of study entry to death. OS will be determined to date of death from any cause. Surviving patients will be censored at the date of last contact.
Time frame
Up to 36 months3
Identification of Site of First Recurrence As Measured By Percentage
Identification of the most common site of first recurrence (SFR) among participants will be reported as a percentage. SFR is defined as the anatomical location of the first documented recurrent lesion and further subcategorized as hepatic and extra-hepatic.
Time frame
Up to 36 months4
Number of Participants Experiencing Treatment Emergent Adverse Events (AEs)
The number of participants experiencing treatment-emergent adverse events (AEs), including treatment-related adverse events (AEs) will be reported. AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Time frame
Up to 13 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Viriom
Collaborator
Joseph and Florence Mandel Family Foundation
Collaborator
Source ClinicalTrials.gov